Clinical Trial and Research Support Services

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Sample Storage, Management, and Processing

When you need a state-of-the-art biobank to focus on your sample management program, so you can focus elsewhere, that's SeraCare...

Turnkey approach | Samples inventoried | Quickly accessible | Available to be processed, analyzed, or characterized to your specifications | Scientific support second to none


Services

Sample Storage

Sample Management

Sample Processing

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Sample Management

You can depend on our highly-trained and licensed technicians, supported by on-staff scientists with expertise in virology, serology, immunology, and molecular biology.

SeraCare Experience

Our sample management services include:

•	Sample transportation to our facilities by a SeraCare engineering team

•	Sample accessibility—your requests filled within 48 hours

•	A wide range of sample processing services

•	Sample kit, SOP, and assay development—we collaborate with principal investigators and clinical trial coordinators to develop, prepare, or optimize, sample kits, SOPs, and assays

•	Sample coordination and distribution—we manage the logistics and ship samples the world over, on your timetable

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Sample Processing

Our bundled portfolio of services can increase the research value, quality, diversity, and longevity of your sample collections.

At SeraCare, we view each sample as an opportunity to create value for our customer.

SeraCare Experience

Sample Analysis

Wide range of analyses available, including whole genome amplification, genotyping, viral load.

Sample Anonymization

Samples from one protocol can be delinked and anonymized for other research purposes. Potential for significant cost savings.

Sample Characterization

To your specifications, including DNA, immune monitoring, cellular hematology, cell differentiation, purification, or isolation.

Sample Processing

Your sample type is isolated. DNA can be extracted from almost any material, and quickly.

Sample Restoration

DNA/RNA can be extracted from nearly any starting material, even materials you might categorize as beyond useful purpose. You won't lose samples due to mishandling or poor material.

Sample Testing

Validation and verification testing, customized to meet your needs.

Sample Transformation

Immortalizes cellular components from your samples, assuring availability for ongoing research purposes. We have a 97% success rate. Samples gain longevity.

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Sample Storage

SeraCare stores and manages over 19 million samples for health agencies, biopharma, hospitals, academic research centers, and clinical research organizations.

SeraCare Experience

Samples are stored in an 80,000-square-foot biobank with:

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24 x 7 restricted-access security

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Redundant power systems, standby freezers, and LN2 tanks with telemetry monitoring

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Each sample bar coded individually, then logged into a real time,
21 CFR Part 11 compliant, inventory management system

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Thorough validation and retirement programs

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Range from room temperature to liquid nitrogen

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PBMC Isolation

SeraCare has been performing basic fractionation of serum and plasma, as well as PBMC isolation, for more than 20 years.

We are currently performing PBMC isolations and cryopreservation in support of several clinical trials and government research contracts.

SeraCare Experience

Typical purity is 0.5-3.0 x 10⁶ PBMCs per whole mL of blood, with greater than 90% viability.


Cryopreserved lots of PBMC also available, including:

•	Full donor demographics

•	HLA-typing

•	Intracellular cytokine responses to IFN-y, IL2

•	Cell Phenotypes CD8, CD3, CD4

•	CD8 and CD4 reactivity to IFN-y

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Biochemistry Support

Our biochemistry group is expert in development and evaluation of a wide range of assays.

We have performed these and other biochemistry services for biopharma customers, and as the central laboratory for both NIAID-sponsored vaccine trials (since 1998) and the Cancer Vaccine Consortium ELISpot proficiency program—a consortium of 35 academic and biopharmaceutical laboratories.

SeraCare Experience

Cellular Hematology and Immunology

SeraCare isolates and analyzes cell populations providing content and cell count.

Cellular Purification and Characterization

SeraCare isolates, cryopreserves, and functionally characterizes individual cell types from peripheral blood.

ELISA Assays

SeraCare provides custom design, processing and analysis of samples by ELISA. Assays are analytically validated assays to determine accuracy, precision, sensitivity, and specificity for each desired ELISA. SeraCare has experience with numerous different cytokines and can analyze any desired cytokine upon request.

ELISpot Analysis

SeraCare isolates cells and enumerates immune responses by ELISpot assay. SeraCare also reads and provides analyses of your ELISpot plates.

Platelet Function and Coagulation

SeraCare analyzes your samples for platelet function and coagulation according to your specifications.

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Molecular Biology Support

Our molecular biology group is expert in DNA and RNA isolations, northern and southern blotting, PCR amplification, in situ hybridization, and DNA cloning/sequencing.

We are well-equipped to perform a wide range of nucleic acid processing and DNA analysis, and we have ongoing competency evaluation and training programs for all molecular activities.

SeraCare Experience

DNA Cloning

SeraCare performs plasmid transformations on your DNA samples. After transformation, individual clones are cultured and plasmid DNA is purified and verified by restriction digestion.

DNA Extraction

SeraCare utilizes the Puregene^® DNA purification procedures from Gentra and the spin column procedure from Qiagen for DNA extraction. We have optimized and validated both procedures under GLP conditions to maximize DNA recovery and maintain DNA purity and integrity using appropriate processing equipment and conditions.

DNA Fragment Purification

SeraCare performs purification of plasmid DNA using Qiagen's plasmid extraction kits. QC and other analyses are performed according to your specifications.

DNA Isolation

SeraCare offers a full range of NAT testing services, including DNA extraction, normalization, sequencing and QC. Your samples can be pooled and aliquoted according to your requirements.

DNA Normalization

SeraCare offers DNA normalization services where the DNA concentration for all the samples is normalized to one concentration per your specifications. SeraCare generally normalizes DNA to 100 +/- 20 μg/ml.

DNA QC

SeraCare provides quality control and DNA fingerprinting services using the AmpFLSTR^® Profiler Plus PCR Amplification Kit from Applied Biosystems and the ABI 3130 DNA Analyzer.

DNA Sequencing

SeraCare performs DNA sequencing services using our high throughput platform ABI 3700 DNA Analyzer, a fully-automated, multi-capillary electrophoresis instrument designed for use in production-scale DNA analysis.

Genomic Library Construction

SeraCare offers custom high-quality genomic and cDNA library construction services. The libraries will be constructed using either plasmid or Lambda phage vectors. Average insert size ranges from 1-4kb in plasmid vector and 10-20kb in Lambda vector with >95% of recombinants. The libraries are provided to you after rigorous Q.C. testing. We also offer normalized and subtracted cDNA services.

Genotyping

SeraCare offers low throughput genotyping services using ABI Assay-on-Demand SNP genotyping products and analysis on ABI 7500 Sequence Detection System.

NAT Testing for Viral Load

SeraCare has CLIA (Clinical Laboratory Improvement Accreditation) certification to perform NAT testing for HIV, HBV, HCV and HPV nucleic acids.

RNA Extraction

SeraCare has a wide range of experience in RNA extractions from various biologic samples. SeraCare has developed and standardized a number of procedures using both the phenol based (TRIzol® from InVitrogen and TRI Reagent^® from Molecular Research Genetics) and column based techniques (RNAqueous^® Kit from Ambion, PAXgene™ from PreAnalytiX, and RNeasy kit from Qiagen).

Whole Genome Amplification

When tissue or blood samples are minimal, SeraCare performs whole genome amplifications utilizing the REPLI-g^® whole genome amplification kit by Qiagen.

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Virology and Immunology Support Services

Our virology and immunology group has a well-established success record in cell and virus culture, including original propagation and cultivation of a wide range of retroviruses from clinical samples.

We have developed and implemented a large number of immunological tests, utilizing various platforms.

SeraCare Experience

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Apoptosis Assays

SeraCare performs apoptosis assays according to customer specifications.

Drug Susceptibility Assays

SeraCare performs an in vitro drug susceptibility assay that measures the extent to which a drug inhibits HIV-1 p24 or HIV-2 p27 antigen production by PBMCs acutely infected with each viral isolate. Coulter assay is used for determining HIV antigen concentration. HIV-1 isolates of any subtype can be tested with PBMCs as the target cells.

EBV Transformation

SeraCare immortalizes cellular components of your samples, assuring availability for ongoing research, with a 97% success rate.

ELISA Assays

ELISpot Assays

SeraCare provides finished ELISpot assay kits from multiple species with multiple cytokines, performs ELISpot analysis, and reads customer-supplied ELISpot plates.

ELISpot Assay Kits

ELISpot Assay kits from multiple species detect and enumerate individual cells that secrete select cytokines in response to stimulation from specific antigens. SeraCare can prepare kits for any species or cytokine requested by customer.

HIV Culture, Characterization, Detection and Quantitation

SeraCare provides HIV cultivation assays as a batch with positive and negative controls. Samples are cultured on Peripheral Blood Mononuclear Cells (PBMCs) for 21 days. Cultures are fed fresh PBMCs on days 7 and 14 following infection. Supernatants are collected twice a week for HIV-1 p24 testing. You receive infectivity results upon completion of the culture evaluation.

HIV Infectivity Assays

SeraCare provides independent, expert analysis of the effectiveness of HIV infectivity of H9 and PBMC samples with HIV.

Viral Agent and Nucleic Acid Preparation

SeraCare has HIV-1 subtypes manufactured under cGMP regulations and used in pharmaceutical and diagnostic research. We isolate and analyze a wide range of targets and can perform specialized services to your specifications.

Viral Assays

SeraCare provides methodologies and platforms to perform NAT testing on viral assays using customer-defined protocols.

Virus Inactivation using BPL or Heat

SeraCare performs viral inactivation by chemical, irradiation, or thermal means.

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SeraCare Experience


	•	We are 30 years into serving customers, including the NIH, CDC, and FDA

	•	We have successfully participated in some of the most demanding clinical trials of the past decade

	•	We have extensive expertise in Biochemistry, Molecular Biology, PBMC Isolation, and Virology and Immunology

	•	We have served as the central laboratory for NIAID-sponsored vaccine trials (since 1998) and for the Cancer Vaccine Consortium ELISpot proficiency program—a consortium of 35 academic and biopharmaceutical laboratories

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Safety & Quality Profile


	•	SeraCare facilities are ISO 9001 and 13485 certified and cGMP compliant

	•	Continuing education and performance benchmarking are mandated for all SeraCare technicians and scientists

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SeraCare Experience


	•	We are 30 years into serving customers, including the NIH, CDC, and FDA

	•	We have successfully participated in some of the most demanding clinical trials of the past decade

	•	We have extensive expertise in Biochemistry, Molecular Biology, PBMC Isolation, and Virology and Immunology

	•	Our molecular biology group is expert in DNA and RNA isolations, northern and southern blotting, PCR amplification, in situ hybridization and DNA cloning/sequencing

	•	We are well-equipped to perform a wide range of nucleic acid processing and DNA analysis, and we have ongoing competency evaluation and training programs for all molecular activities

Close All Close Move
SeraCare Experience


	•	We are 30 years into serving customers, including the NIH, CDC, and FDA

	•	We have successfully participated in some of the most demanding clinical trials of the past decade

	•	We have extensive expertise in Biochemistry, Molecular Biology, PBMC Isolation, and Virology and Immunology

	•	We have been performing basic fractionization of serum and plasma and PBMC isolation for more than 20 years

	•	We currently perform PBMC isolations and cryopreservation in support of several clinical trials and government research contracts

	•	Typical purity is 0.5-3.0 x 10⁶ PBMCs per whole mL of blood, with greater than 90% viability.

Close All Close Move
SeraCare Experience


	•	We are 30 years into serving customers, including the NIH, CDC, and FDA

	•	We have successfully participated in some of the most demanding clinical trials of the past decade

	•	We have extensive expertise in Biochemistry, Molecular Biology, PBMC Isolation, and Virology and Immunology

	•	Our virology and immunology group has a well-established success record in cell and virus culture, including original propagation and cultivation of a wide range of retroviruses from clinical samples

	•	We have developed and implemented a large number of immunological tests, utilizing various platforms

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Safety & Quality Profile


	•	SeraCare manufacturing facilities are ISO 9001 and ISO 13485 certified and cGMP compliant

	•	SeraCare is compliant with all Good Practices, including GLP and GCP

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SeraCare Experience


•	We are 30 years into serving customers, including the NIH, CDC, and FDA

•	We have successfully participated in some of the most demanding clinical trials of the past decade

•	We manage every size collection—a hundred samples to a million, including
	—	cell banks, tissue, sera, plasma, slides, and nucleic acids

•	We are GxP compliant with flexibility to adjust to your requirements, protocols, or procedures